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High RiskFDA
Kerry Foods
KERRY, PARM. LING. 5734, SEA 5734, CONTAINS MILK, Item # 15734.607, , Net Wt 1000 Lb (453.556 Kg)
Dairy·4 affected·Jun 1, 2012
High RiskFDA
Bracco Diagnostics Inc
CARDIOGEN-82 (Rubidium Rb 82 Generator), 140 millicurie, Rx Only, For Elution of sterile nonpyrogenic Rubidium Chloride Rb 82, Manufactur...
Drugs·54 affected·Jun 1, 2012
High RiskFDA
Sysmex America, Inc.
Sysmex XE-2100C Automated Hematology System; an automated differential cell counter; Sysmex Corporation, Kobe, Japan; Sysmex America, On...
Diagnostic Devices·69 affected·Jun 1, 2012
High RiskFDA
Stryker Instruments Div. Of Stryker Corporation
T5 Hytrel Zipper Toga. Product Usage: The togas are intended to provide a barrier between the operating room and the members of the ...
Surgical Devices·23,653 affected·Jun 1, 2012
High RiskFDA
Psc Industries Inc
Bayonet Forceps 7.-1/8 (181.0mm) 0.75mm Non-Insulated Tips, Sterile Single Use Surgical/Bipolar Forceps, Model #20-1360K 510 (k) #K884656...
Surgical Devices·40 affected·Jun 1, 2012
High RiskFDA
Psc Industries Inc
Bayonet Forceps 7.75" (196.9 mm) 0.5 mm Tips Non-Stick Electrosurgical/Bipolar Forceps/Reusable, Model #90-7004 (k) #K982705. The surgi...
Surgical Devices·7 affected·Jun 1, 2012
High RiskFDA
Advanced Sterilization Products
CIDEX OPA, High Level Disinfectant Solution, Glutaraldehyde-free (0.55% ortho-phthaladehyde) solution. The CIDEX OPA solution is intended...
Medical Devices·1,310,844 affected·Jun 1, 2012
High RiskFDA
Psc Industries Inc
Irrigating Bayonet Forceps 8.25" (209.6 mm) 1.5 mm Tips, Electrosurgical Irrigating Bipolar Forceps, Model #20-0431, 510 (k) #K072937. Ea...
Surgical Devices·125 affected·Jun 1, 2012
High RiskFDA
Psc Industries Inc
Bayonet Forceps 8.5" (215.9mm) Serrated 1.0 mm Tips Electrosurgical/Monopolar Forceps/Reusable, Model #41604, 510 (k) #K885199. The surgi...
Surgical Devices·5 affected·Jun 1, 2012
High RiskFDA
Psc Industries Inc
Bayonet Forceps 7.-1/8 (181.0mm) 0.75mm Insulated Tips, Sterile Single Use Surgical/Bipolar Forceps, Model #20-1360I, 510 (k) #K884656. ...
Surgical Devices·80 affected·Jun 1, 2012
High RiskFDA
I-flow Llc
I-Flow ON-Q Pain Relief System, T-Block Needle/Catheter Tray, Model #TBTB1089T The intended use of each component in the finished fina...
Medical Implants·450 affected·Jun 1, 2012
High RiskFDA
I-flow Llc
I-Flow ON-Q Pain Relief System, T-Block Needle/Catheter Kit, Model #TB089T The intended use of each component in the finished final tr...
Medical Implants·75 affected·Jun 1, 2012
High RiskFDA
Sysmex America, Inc.
Sysmex XE-5000 Automated Hematology System; an automated differential cell counter; Sysmex Corporation, Kobe, Japan; Sysmex America, One...
Diagnostic Devices·763 affected·Jun 1, 2012
High RiskFDA
The Broaster Company, Llc
Broaster Fish Coating, 96627, Ingredients: Corn Meal, Wheat Flour, Corn Crumbs, Salt, Spices, Paprika, Citric Acid, Onion, Sugar, Garlic,...
Seafood·89 affected·May 31, 2012
High RiskFDA
Biomet 3i, Llc
Low Profile Abutment, Non-Hexed Castable Cylinder Model LPCCC1. Product is labeled in part: "***REF LPCCC1***Low profile Abutment Hexed...
Medical Devices·611 affected·May 31, 2012
High RiskFDA
Vistapharm, Inc.
Hydrocodone Bitartrate & Acetaminophen Oral Solution 7.5 mg/325 mg per 15 mL, a) 15 mL Unit Dose Cups (50 unit dose cups per case), b) 47...
Oral Drugs·949 affected·May 30, 2012
High RiskFDA
Salter Labs
Adult Divided Cannula end tidal C)2 sampling w/male luer-lock connector. 7 ft, oxygen tube, 7 ft. CO2 tube RX only.For Single Patient U...
Respiratory Devices·242 affected·May 30, 2012
High RiskFDA
Maquet Inc.
Maquet Getinge Group Pediatric Arterial Cannula Maquet Cardiopulmonary AG Kehler Strabe 31 76437 Rastatt Germany Phone +49 7222 932-0 ...
Medical Devices·20 affected·May 29, 2012
High RiskFDA
Trumpf Medical Systems, Inc.
Acrobat 3000 (AC3000) Spring Arm as support arm for iLED operating lights, TRUMPF Medizinsysteme GmbH + Co KG 82178 Puchheim. The TRUM...
Surgical Devices·402 affected·May 29, 2012
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
EasyLink Informatic System is included with the Dimension Vista System. The Dimension Vista Integrated System is an in vitro diagnostic ...
Diagnostic Devices·637 affected·May 29, 2012
High RiskFDA
Ge Healthcare, Llc
Advantage Workstation Volume Share 2 (versionAW4.4_04) with Volume Viewer 3 and 3.1 (version7.0 to version7.5 and version 8.1) and only w...
Medical Implants·548 affected·May 29, 2012
High RiskFDA
Franck's Lab Inc., D.b.a. Franck's Compounding Lab
ALPROSTADIL 10MCG/ML INJECTABLE 10 ML, 20 ML, 3 ML, 30 ML, 5 ML, 6 ML; ALPROSTADIL 15MCG/ML INJECTABLE 5 ML; ALPROSTADIL 20MCG/ML INJE...
Injectable Drugs·529 affected·May 25, 2012
High RiskFDA
Franck's Lab Inc., D.b.a. Franck's Compounding Lab
AFLIBERCEPT, SDPF - (0.05ML SYRINGE, 31G, 5/16") 40MG/ML INJECTABLE 0.35 ML, 0.95 ML, 1.25 ML (3 DIFFERENT PRODUCTS)
Injectable Drugs·4 affected·May 25, 2012
High RiskFDA
Franck's Lab Inc., D.b.a. Franck's Compounding Lab
CYCLOPENT/PHENYLEPH/TROPICAMIDE/PROPARACAINE 2%/2.5%/1%/0.5% OPHTHALMIC 5 ML (1 PRODUCT)
Ophthalmic Drugs·1 affected·May 25, 2012
High RiskFDA
Franck's Lab Inc., D.b.a. Franck's Compounding Lab
EPINEPHRINE **(25X1ML AMPULS) 1:1000 1MG/ML INJECTABLE 25 ML; EPINEPHRINE HCL SOLUTION 1% OPHTHALMIC 10 ML, 20 ML; EPIINEPHRINE P.F. (SU...
Injectable Drugs·33 affected·May 25, 2012
High RiskFDA
Franck's Lab Inc., D.b.a. Franck's Compounding Lab
ENGERIX-B, SDV** 20MCG/ML INJECTABLE 1 ML (1 PRODUCT)
Injectable Drugs·1 affected·May 25, 2012
High RiskFDA
Franck's Lab Inc., D.b.a. Franck's Compounding Lab
ATROPINE SULFATE 0.4MG/ML INJECTABLE 12 ML, 2 ML, 20 ML, 24 ML, 25 ML, 3 ML; ATROPINE/EPINEPHRINE/ BSS 0.02MG/0.1MG/ML INJECTABLE 10 ML,...
Injectable Drugs·32 affected·May 25, 2012
High RiskFDA
Franck's Lab Inc., D.b.a. Franck's Compounding Lab
FORSKOLIN/PHENTOLAMINE 200MCG / 2MG INJECTABLE 5 ML (1 PRODUCT)
Injectable Drugs·2 affected·May 25, 2012
High RiskFDA
Franck's Lab Inc., D.b.a. Franck's Compounding Lab
CEFTAZIDIME OPHTHALMIC, P.F. 22.5MG/ML (2.25%) OPHTHALMIC 1 ML, 2ML, 2 MLS, 6 ML CEFTAZIDIME, ...
Injectable Drugs·197 affected·May 25, 2012
High RiskFDA
Franck's Lab Inc., D.b.a. Franck's Compounding Lab
DROPTAINER STERILE PLASTIC (2 X 7ML) 10 BOTTLE 4 PK (2 DIFFERENT PRODUCTS)
Drugs·2 affected·May 25, 2012
High RiskFDA
Franck's Lab Inc., D.b.a. Franck's Compounding Lab
HYDROXOCOBALAMIN**(VIT B-12) 1000MCG/ML INJECTABLE 30 ML Injectable (4 DIFFERENT PRODUCTS)
Injectable Drugs·7 affected·May 25, 2012
High RiskFDA
Franck's Lab Inc., D.b.a. Franck's Compounding Lab
ACYCLOVIR OPHTHALMIC 3% OINTMENT 5 GM; ACYCLOVIR OPHTHALMIC 3% SOLUTION 5 ML (2 DIFFERENT PRODUCTS)
Topical Drugs·3 affected·May 25, 2012
High RiskFDA
Franck's Lab Inc., D.b.a. Franck's Compounding Lab
HYALURONIDASE / LIDOCAINE 7.1U/9.5MG/ML INJECTABLE 105 ML, 210 ML (6 DIFFERENT PRODUCTS)
Injectable Drugs·17 affected·May 25, 2012
High RiskFDA
Franck's Lab Inc., D.b.a. Franck's Compounding Lab
HYDROMORPHONE/CLONIDINE P. F. 120MG/1.3MCG/ML INTRATHECAL 10 ML; HYDROMORPHONE/CLONIDINE P. F. 120MG/1.8MCG/ML INTRATHECAL 10 ML; HYDROMO...
Drugs·7 affected·May 25, 2012
High RiskFDA
Franck's Lab Inc., D.b.a. Franck's Compounding Lab
CYCLOSPORINE (A) AQUEOUS (HUMAN) 0.5% OPHTHALMIC 10 ML, 5 ML; CYCLOSPORINE (A) AQUEOUS PF (HUMAN) 0.2% OPHTHALMIC 10 ML; CYCLOSPORI...
Ophthalmic Drugs·40 affected·May 25, 2012
High RiskFDA
Franck's Lab Inc., D.b.a. Franck's Compounding Lab
DEXAMETHASONE/BACTERIOSTATIC WATER IONTOPHORESIS 0.5MG/5ML(0.1MG/ML) INJECTABL 30 ML (1 PRODUCT) ...
Injectable Drugs·1 affected·May 25, 2012
High RiskFDA
Franck's Lab Inc., D.b.a. Franck's Compounding Lab
DMSO/HEPARIN/METHYLPREDNISOLONE 50%/5000U/40MG/50ML SOLUTION 300 MLS (1 PRODUCT)
Drugs·2 affected·May 25, 2012
High RiskFDA
Franck's Lab Inc., D.b.a. Franck's Compounding Lab
G-C-P 0.1%/0.1%/0.05% SOLUTION 250 ML, 250 MLS, 500 ML (3 DIFFERENT PRODUCTS)
Drugs·6 affected·May 25, 2012
High RiskFDA
Franck's Lab Inc., D.b.a. Franck's Compounding Lab
CHROMIUM PICOLINATE 200MCG/ML INJECTABLE 60 ML (1 PRODUCT)
Injectable Drugs·4 affected·May 25, 2012
High RiskFDA
Franck's Lab Inc., D.b.a. Franck's Compounding Lab
HYDROXYPROGESTERONE CAPROATE 250MG/ML INJECTABLE 10 ML, 12 ML, 13 ML, 15 ML, 3 ML, 30 ML, 4 ML, 5 ML, 6 ML, 7 ML, 9 ML (11 DIFFERENT PROD...
Injectable Drugs·48 affected·May 25, 2012
High RiskFDA
Franck's Lab Inc., D.b.a. Franck's Compounding Lab
FENTANYL, P.F. 100MCG/ML INJECTABLE 12 ML, 2 ML, 30 ML, 60 ML; FENTANYL, P.F. 50MCG/ML (100MCG/2ML) INJECTABLE 100 ML, 120 ML, 150 ML, 2...
Injectable Drugs·110 affected·May 25, 2012
High RiskFDA
Franck's Lab Inc., D.b.a. Franck's Compounding Lab
HYDROMORPHONE P.F. 20MG/ML INTRATHECAL 40 ML; HYDROMORPHONE P.F. 25MG/ML INTRATHECAL 18 ML; HYDROMORPHONE P.F. 30MG/ML INTRATHECAL 18 ML...
Drugs·8 affected·May 25, 2012
High RiskFDA
Franck's Lab Inc., D.b.a. Franck's Compounding Lab
HYALURONIDASE - PRESERVATIVE FREE 150 U/ML INJECTABLE 1 MLS, 10 MLS, 100 MLS, 12 MLS, 12.5 ML, 120 MLS, 15 MLS, 16 ML, 16 MLS, 2 MLS, 20 ...
Injectable Drugs·326 affected·May 25, 2012
High RiskFDA
Franck's Lab Inc., D.b.a. Franck's Compounding Lab
ACETYLCYSTEINE, OPHTHALMIC IN ARTIFICIAL TEARS 10% SOLUTION 10 ML, 2 ML, 5 ML, 6 ML; ACETYLCYSTEINE, OPHTHALMIC IN ARTIFICIAL TEARS 2.5% ...
Ophthalmic Drugs·16 affected·May 25, 2012
High RiskFDA
Franck's Lab Inc., D.b.a. Franck's Compounding Lab
BUPIVACAINE/SUFENTANIL, P.F. 15MG/150MCG/ML INTRATHECAL 20 ML (1 PRODUCT)
Drugs·2 affected·May 25, 2012
High RiskFDA
Franck's Lab Inc., D.b.a. Franck's Compounding Lab
BRILLIANT BLUE G, P.F. 0.025% OPHTHALMIC 10 ML, 20 ML, 26 ML, 4 ML; BRILLIANT BLUE G, P.F. (0.5ML SYRINGE) 0.25MG/ML OPHTHALMIC 2 ML, 2...
Ophthalmic Drugs·107 affected·May 25, 2012
High RiskFDA
Franck's Lab Inc., D.b.a. Franck's Compounding Lab
BIEST(80/20) 6.25MG/GM (1.25MG/0.2ML) I-CREAM 6 ML (5 DIFFERENT PRODUCTS)
Topical Drugs·7 affected·May 25, 2012
High RiskFDA
Franck's Lab Inc., D.b.a. Franck's Compounding Lab
BUPIVACAINE/CLONIDINE/HYDROMORPHONE, P.F. 20MG/400MCG/2MG/ML INTRATHECAL; BUPIVACAINE/CLONIDINE/HYDROMORPHONE, P.F. 7.5MG/1.5MCG/50MG/ML ...
Drugs·5 affected·May 25, 2012